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Restylane Lyps with Lidocaine (1 x 1.0 ml)

Restylane Lyps with Lidocaine (1 x 1.0 ml)

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid dermal filler for aesthetic lip augmentation and perioral line correction in applicable markets.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) with BDDE crosslinking, in conformity with quality and safety standards for sterile injectable medical devices.
  • Subject to post Market surveillance and adverse event (device vigilance) reporting requirements in countries where it is marketed.
Hyaluronic Acid Dermal Filler \u2013 Lip Filler for Natural Fullness

Description

Restylane Lyps with Lidocaine is a sterile, transparent injectable dermal filler specifically formulated for lip augmentation and the correction of lines around the mouth. It consists of non-animal stabilized hyaluronic acid (NASHA) at 20 mg/mL, cross-linked with BDDE, combined with 0.3% lidocaine hydrochloride in phosphate buffered saline. Designed to withstand the constant movement and mechanical stress of the lips, the soft yet resilient gel enhances lip fullness, defines the vermilion border and helps smooth upper lip lines while maintaining a natural look and feel. The product is supplied as a single-use 1.0 ml pre-filled glass syringe for administration by qualified healthcare professionals.

Bnefits

  • Enhances lip volume and fullness while maintaining a soft, natural feel.
  • Defines and augments the lip body and vermilion border for improved shape and contour.
  • Helps smooth upper lip (smoker’s) lines and perioral fine lines.
  • Formulated to withstand the constant movement of the lips from talking, smiling and eating.
  • Soft enough for the delicate lip tissue yet durable enough to resist rapid degradation.
  • Contains 0.3% lidocaine to reduce injection discomfort and improve patient tolerance.
  • Non-animal stabilized hyaluronic acid (NASHA) with an established safety and biocompatibility profile.
  • Immediate visible results after treatment, with longevity typically 6–9 months and sometimes up to 12 months.
  • Single-use, sterile syringe with traceability labels to support safe clinical practice.

Indications

  • Lip augmentation to increase volume and fullness in adult patients.
  • Enhancement and definition of the vermilion border and lip contours.
  • Correction and softening of upper lip lines and perioral (smoker’s) lines.
  • General improvement of lip symmetry and shape when a soft lip-specific filler is appropriate.
  • Use only by appropriately trained and legally authorised healthcare professionals in accordance with the Instructions for Use and local regulations.

Composition

  • Non-animal stabilized sodium hyaluronate (hyaluronic acid) 20 mg/mL.
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine).
  • Phosphate buffered saline, pH ~7, q.s. to 1.0 mL.
  • Crosslinking agent: BDDE (1,4-butanediol diglycidyl ether).
  • Sterile, clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel at 20 mg/mL with integrated 0.3% lidocaine hydrochloride in phosphate buffered saline (pH ~7), produced using NASHA technology to give a soft yet resilient gel optimised for lip tissue. Supplied in a single-use, pre-filled 1.0 ml glass syringe for submucosal and/or superficial subcutaneous implantation in and around the lips.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Lyps with Lidocaine.
  • 2 x sterile 29G 1/2" disposable needles supplied in the blister (or as specified on the local pack).
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Luer-lock syringe with tamper-evident cap to maintain sterility until use.
  • Outer carton printed with product name, volume, batch/lot number, expiry date, manufacturer and regulatory markings.
  • Traceability / patient record labels included for insertion into patient medical records.

Usage

  • For professional use only: Restylane Lyps with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in lip anatomy and dermal filler injections.
  • Before use, inspect the outer carton, blister and syringe; do not use if packaging is damaged, sterility is compromised, the gel appears cloudy or contains particles, or if the product is past its expiry date.
  • Obtain a full medical history including allergies (particularly to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune diseases, and previous aesthetic treatments or implants in the lip area.
  • Cleanse and disinfect the lips and surrounding skin according to clinic protocol for injectable procedures.
  • Attach one of the supplied 29G 1/2" sterile needles (or another compatible needle/cannula within the recommended gauge range) securely to the luer-lock syringe using aseptic technique and expel any air prior to injection.
  • Inject Restylane Lyps into the appropriate plane, generally the submucosal layer of the lip for volume and into the superficial subcutaneous tissue or vermilion border for contouring, following the Instructions for Use.
  • Use suitable injection techniques (e.g. serial puncture, linear threading, fanning) with small aliquots and slow, controlled injection; aspirate where appropriate to reduce risk of intravascular injection.
  • Avoid overcorrection; build the desired volume and definition gradually and symmetrically. Gently mould or massage the lips if needed to ensure even distribution and smooth contours, taking care not to compress the tissue excessively.
  • Do not inject into areas with active infection, inflammation or lesions such as herpes labialis (cold sores). Stop injection immediately if the patient reports severe pain or if blanching or other signs of vascular compromise occur, and manage according to current clinical guidelines.
  • After treatment, advise the patient to avoid makeup on or around the lips for several hours and to avoid excessive manipulation, very hot or cold foods and drinks, smoking, alcohol, and extreme temperatures (saunas, sunbeds) for a short period as per clinic protocol.
  • Record the product name, batch/lot number, injection sites and volumes, and any immediate reactions in the patient’s medical record using the supplied traceability labels.

Contraindications

  • History of severe allergies or anaphylactic reactions, or the presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any other component of the product, including gram-positive bacterial proteins.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin or mucosal disease, inflammation, infection or lesions (including herpes labialis) at or near the intended injection site.
  • Intravascular injection is strictly contraindicated; the product must not be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended for submucosal and/or superficial subcutaneous implantation only as specified in the Instructions for Use.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers.
  • Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
  • Use in patients below the minimum age specified in local regulations and the product’s approved labelling (typically adults over 18 or 21 years, depending on jurisdiction).

Adverse Effects

  • Common, usually transient injection-site reactions such as swelling, redness (erythema), tenderness, pain, itching and bruising of the lips and surrounding area.
  • Localized lumps, bumps, nodules or unevenness in the lips, which are often temporary but may require massage or further management.
  • Injection-site hematoma or ecchymosis, especially in patients with increased bleeding tendency or on anticoagulant/antiplatelet therapy.
  • Temporary alterations in sensation such as numbness, tingling or tightness in the lips due to lidocaine and injection trauma.
  • Localized inflammatory reactions including swelling and redness, which may appear immediately or be delayed and generally resolve spontaneously.
  • Infection at or near the injection site if aseptic technique is not fully observed.
  • Delayed inflammatory reactions, granuloma formation or persistent nodules that may require medical treatment, including possible use of hyaluronidase.
  • Rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, ischemia, tissue necrosis or visual disturbance/vision loss, requiring urgent medical attention.
  • Post-inflammatory hyperpigmentation, scarring or other changes in lip colour and texture, particularly in susceptible individuals.
  • Unsatisfactory cosmetic result or asymmetry that may necessitate correction, additional treatment or dissolution of the filler with hyaluronidase.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at a controlled temperature, typically between 2°C and 25°C, as indicated on the packaging and Instructions for Use.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the sterile blister or syringe packaging has been opened or damaged before use.

Duration

Results are immediate after injection; clinical effect usually lasts 6 to 9 months, and in some patients up to approximately 12 months, depending on individual factors such as metabolism, age, lifestyle, treatment area and injection technique.

Onset

Visible enhancement of lip volume and contour is generally immediate after injection, with the final aesthetic result evident once initial swelling and redness resolve, typically within several days up to about 2 weeks.

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